(91 days)
Not Found
None
No
The summary describes a patient examination glove, a simple medical device, and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device, a patient examination glove, is intended to prevent contamination, not to treat or cure a disease or condition.
No
The device is described as a "patient examination glove," which prevents contamination between patient and examiner. This function is protective, not diagnostic. A diagnostic device would typically be used to identify, measure, or monitor a disease or condition.
No
The device description clearly states "PRE POWDERED LATEX PATIENT EXAMINATION GE", indicating a physical glove, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove" worn on the hand or finger to prevent contamination between patient and examiner. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description "PRE POWDERED LATEX PATIENT EXAMINATION GE" further supports its nature as a physical barrier device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening
- Using reagents or assays
Therefore, based on the provided text, this device is a medical device used for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
According to 21 CFR, a patient examination glove is a disposable device intended for medical purpose that is worn on the examiner 's hand or finger to prevent contamination between patient and examiner.
Product codes
LYY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem depicts a stylized eagle or bird-like figure with three curved lines representing its wings or body. The overall design is simple and conveys a sense of government authority and public service.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Safe Glove Ltd. C/O Ed Sing Official U.S. Correspondent 4309 West Poinsettia Drive Glendale, Arizona 85304
K973831 Re: Pre-Powdered Patient Latex Examination Glove Trade Name: Requlatory Class: I Product Code: LYY Dated: December 16, 1997 Received: December 16, 1997
Dear Mr. Sing:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
JAN - 6 1998
1
Page 2 - Mr. Sing
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatanowski
Timo A Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows a logo with a triangle shape. Inside the triangle, there are the letters 'SG' stacked on top of each other. Below the letters, there is some text in a foreign language, followed by the words 'SAFE GLOVE CO., LTD.' The logo appears to be for a company called Safe Glove Co., Ltd.
DAD PRATUMWAN DISTRICT BANGKOK 10330. THAILAND. UR MUANG SURATTHANI THAILAND.
510(k) Number (if known): K 973831
Device Name: PRE POWDERED LATEX PATIENT EXAMINATION GE
Indications For Use: According to 21 CFR, a patient examination glove is a disposable device intended for medical purpose that is worn on the examiner 's hand or finger to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chiu S. Lin
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K973831
Prescription Use (Pcc 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)